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Cochrane Database of Systematic Reviews

Intervenciones para el tratamiento de la colitis linfocítica

Información

DOI:
https://doi.org/10.1002/14651858.CD006096.pub4Copiar DOI
Base de datos:
  1. Cochrane Database of Systematic Reviews
Versión publicada:
  1. 13 julio 2017see what's new
Tipo:
  1. Intervention
Etapa:
  1. Review
Grupo Editorial Cochrane:
  1. Grupo Cochrane de Salud digestiva

Copyright:
  1. Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Autores

  • Nilesh Chande

    Correspondencia a: London Health Sciences Centre ‐ Victoria Hospital, London, Canada

    [email protected]

    [email protected]

  • Noor Al Yatama

    Department of Medicine, University of Western Ontario, London, Canada

  • Tania Bhanji

    Department of Medicine, University of Western Ontario, London, Canada

  • Tran M Nguyen

    Cochrane IBD Group, Robarts Clinical Trials, London, Canada

  • John WD McDonald

    Cochrane IBD Group, Robarts Clinical Trials, London, Canada

  • John K MacDonald

    Department of Medicine, University of Western Ontario, London, Canada

    Cochrane IBD Group, Robarts Clinical Trials, London, Canada

Declarations of interest

Nilesh Chande: Dr Chande has received fees for consultancy from AbbVie, Janssen, Takeda, and Ferring, and fees for lectures from AbbVie, Actavis and Janssen. All of these financial activities are outside the submitted work.

Noor Al Yatama: None known

Tania Bhanji: None known

Tran M Nguyen: None known

John WD McDonald: None known

John K MacDonald: None known

Acknowledgements

Partial funding for the Cochrane IBD Group (April 1, 2016 ‐ March 31, 2018) has been provided by Crohn's and Colitis Canada (CCC).

Version history

Published

Title

Stage

Authors

Version

2017 Jul 13

Interventions for treating lymphocytic colitis

Review

Nilesh Chande, Noor Al Yatama, Tania Bhanji, Tran M Nguyen, John WD McDonald, John K MacDonald

https://doi.org/10.1002/14651858.CD006096.pub4

2008 Apr 23

Interventions for treating lymphocytic colitis

Review

Nilesh Chande, John WD McDonald, John K MacDonald

https://doi.org/10.1002/14651858.CD006096.pub3

2007 Jan 24

Interventions for treating lymphocytic colitis

Review

Nilesh Chande, John WD McDonald, John K MacDonald

https://doi.org/10.1002/14651858.CD006096.pub2

2006 Jul 19

Interventions for treating lymphocytic colitis

Protocol

Nilesh Chande, John WD McDonald, John K MacDonald

https://doi.org/10.1002/14651858.CD006096

Keywords

MeSH

PICO

Population
Intervention
Comparison
Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Study flow diagram.
Figuras y tablas -
Figure 1

Study flow diagram.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Figuras y tablas -
Figure 2

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Comparison 1 Bismuth subsalicylate versus placebo, Outcome 1 Clinical response.
Figuras y tablas -
Analysis 1.1

Comparison 1 Bismuth subsalicylate versus placebo, Outcome 1 Clinical response.

Comparison 1 Bismuth subsalicylate versus placebo, Outcome 2 Histological response.
Figuras y tablas -
Analysis 1.2

Comparison 1 Bismuth subsalicylate versus placebo, Outcome 2 Histological response.

Comparison 2 Budesonide versus placebo, Outcome 1 Clinical response.
Figuras y tablas -
Analysis 2.1

Comparison 2 Budesonide versus placebo, Outcome 1 Clinical response.

Comparison 2 Budesonide versus placebo, Outcome 2 Histological response.
Figuras y tablas -
Analysis 2.2

Comparison 2 Budesonide versus placebo, Outcome 2 Histological response.

Comparison 2 Budesonide versus placebo, Outcome 3 Adverse events.
Figuras y tablas -
Analysis 2.3

Comparison 2 Budesonide versus placebo, Outcome 3 Adverse events.

Comparison 3 Mesalazine versus mesalazine + cholestyramine, Outcome 1 Clinical response.
Figuras y tablas -
Analysis 3.1

Comparison 3 Mesalazine versus mesalazine + cholestyramine, Outcome 1 Clinical response.

Comparison 3 Mesalazine versus mesalazine + cholestyramine, Outcome 2 Histological response.
Figuras y tablas -
Analysis 3.2

Comparison 3 Mesalazine versus mesalazine + cholestyramine, Outcome 2 Histological response.

Comparison 4 Beclometasone dipropionate versus mesalazine, Outcome 1 Clinical response at 8 weeks.
Figuras y tablas -
Analysis 4.1

Comparison 4 Beclometasone dipropionate versus mesalazine, Outcome 1 Clinical response at 8 weeks.

Comparison 4 Beclometasone dipropionate versus mesalazine, Outcome 2 Maintenance of clinical response at 12 months.
Figuras y tablas -
Analysis 4.2

Comparison 4 Beclometasone dipropionate versus mesalazine, Outcome 2 Maintenance of clinical response at 12 months.

Summary of findings for the main comparison. Bismuth subsalicylate versus placebo for treating lymphocytic colitis

Bismuth subsalicylate versus placebo for treating lymphocytic colitis

Patient or population: patients with active lymphocytic colitis
Settings: outpatient
Intervention: bismuth subsalicylate versus placebo

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

control

bismuth vs placebo

Clinical response

0 per 10001

0 per 1000

RR 5.25
(0.94 to 1.90)

5
(1 study)

⊕⊝⊝⊝
very low,2,3

Histological response

500 per 10001

665 per 1000

(135 to 3300)

RR 1.33

(0.27 to 6.6)

5

(1 study)

⊕⊝⊝⊝
very low2,3

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio;

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 Control group risk estimates come from control arm of meta‐analysis, based on included trials.
2 Downgraded one level due to unclear risk of bias for allocation concealment.
3 Downgraded two levels due to very sparse data (3 events).

Figuras y tablas -
Summary of findings for the main comparison. Bismuth subsalicylate versus placebo for treating lymphocytic colitis
Summary of findings 2. Budesonide versus mesalazine for treating lymphocytic colitis

Budesonide versus mesalazine for treating lymphocytic colitis

Patient or population: patients with active lymphocytic colitis
Settings: outpatient
Intervention: budesonide versus placebo

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

control

budesonide versus placebo

Clinical response

440 per 10001

893 per 1000
(550 to 1000)

RR 2.03
(1.25 to 3.33)

57
(2 studies)

⊕⊕⊝⊝

low2,3

Histological response

313 per 10001

763 per 1000
(353 to 1000)

RR 2.44

(1.13 to 5.28)

39
(2 studies)

⊕⊕⊝⊝

low4

Adverse events

143 per 10001

96 per 1000

(17 to 513)

RR 0.67

(0.12 to 3.59)

42
(1 study)

⊕⊕⊝⊝

low5

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: risk ratio;

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 Control group risk estimates come from control arm of meta‐analysis, based on included trials.
2 Downgraded one level due to unclear risk of bias for blinding or participants and personnel
3 Downgraded one level due to sparse data (39 events).
4 Downgraded two levels due to very sparse data (23 events).
5 Downgraded two levels due to very sparse data (5 events).

Figuras y tablas -
Summary of findings 2. Budesonide versus mesalazine for treating lymphocytic colitis
Summary of findings 3. Mesalazine versus mesalazine + cholestyramine for treating lymphocytic colitis

Mesalazine versus mesalazine + cholestyramine for treating lymphocytic colitis

Patient or population: patients with maintenance of remission in lymphocytic colitis
Settings: outpatient
Intervention: Mesalazine versus mesalazine + cholestyramine

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

mesalazine

mesalazine plus cholestyramine

Clinical response

857 per 1000

849 per 1000

(660 to 1000)

RR 0.99
(0.77 to 1.28)

41
(1 study)

⊕⊕⊝⊝
low ,2,3

Histological response

857 per 1000

849 of 1000

(660 to 1000)

RR 0.99
(0.77 to 1.28)

41
(1 study)

⊕⊕⊝⊝
low ,2,3

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio;

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 Control group risk estimates come from control arm of meta‐analysis, based on included trials.
2 Downgraded one level due to high risk of bias (no blinding) and unclear allocation concealment
3 Downgraded one level due to sparse data (35 events)

Figuras y tablas -
Summary of findings 3. Mesalazine versus mesalazine + cholestyramine for treating lymphocytic colitis
Summary of findings 4. Beclometasone dipropionate versus mesalazine for treating lymphocytic colitis

Beclometasone dipropionate versus mesalazine for treating lymphocytic colitis

Patient or population: Patients with active or quiescent lymphocytic colitis
Settings: outpatient
Intervention: Beclometasone dipropionate versus mesalazine

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Mesalazine

beclometasone

Clinical response at 8 weeks

867 per 10001

841 per 1000

(650 to 1075)

RR 0.97

(0.75 to 1.24)

46
(1 study)

⊕⊕⊝⊝

low2,3

Maintenance of clinical response at 12 weeks

200 of 10001

258 per 1000

(80 to 836)

RR 1.29

(0.40 to 4.18)

46
(1 study)

⊕⊝⊝⊝

very low2,4

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio;

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 Control group risk estimates come from control arm of meta‐analysis, based on included trials.
2 Downgraded one level due to high risk of bias (no blinding) .
3 Downgraded one level due to sparse data (39 events)
4 Downgraded two levels due to very sparse data (11 events)

Figuras y tablas -
Summary of findings 4. Beclometasone dipropionate versus mesalazine for treating lymphocytic colitis
Table 1. Non‐randomized studies of therapies for lymphocytic colitis

Therapy

References

Antiallergic therapy

Weidenhiller 2005

Antibiotics

Baert 1999; Hilmer 2006; Mullhaupt 1998; Olesen 2004b; Puri 1994; Swensson 1999

Antidiarrheal agents

Baert 1999; Fekih 2006; Fernandez 2003; Hilmer 2006; Hollerweger 2003; Mullhaupt 1998; Olesen 2004b; Pardi 2002; Wang 1999

Azathioprine/6‐mercaptopurine

Ben Soussan 2001; Pardi 2001; Pardi 2002; Vennamaneni 2001

Bile acid binding agents

Baert 1999; Baert 2004; Einarsson 1992; Fernandez 2001; Fernandez 2003; Mahmoud 2005; Olesen 2004b; Pardi 2002; Ung 2002

Bismuth subsalicylate

Bohr 1999; Fine 1998; Pardi 2002

Budesonide

Barta 2005; Chopra 2006; Fomegne 2005; Hollerweger 2003; Olesen 2004b; Van Gossum 1998; Wiedermann 2007

Bulking agents

Olesen 2004b

Corticosteroids (traditional)

Baert 1999; Bonner 2000; Olesen 2004b; Fernandez 2003; Kitchen 2002; Pardi 2002; Persoz 2001; Sandmeier 2004; Swensson 1999; Wang 1999

Cyclosporine

Eijsbouts 1995

Dietary modification/ or elemental diet (check)

Fekih 2006; Baert 1999; Jensen 2005; Teahon 1994; Weidenhiller 2005

Probiotics

Rohatgi 2015; Taheri 2011

Spasmolytics

Mullhaupt 1998

Sulfasalazine/other 5‐ASA

Abdo 2001; Baert 1999; Bonner 2000; De Waele 1994; Fekih 2006; Fernandez 2003; Hollerweger 2003; Kitchen 2002; Mennecier 1999; Mullhaupt 1998; Netzer 1997;p Olesen 2004b; Pardi 2002; Perk 1999; Wang 1999

Surgery

Varghese 2002; Yusuf 1999

Figuras y tablas -
Table 1. Non‐randomized studies of therapies for lymphocytic colitis
Comparison 1. Bismuth subsalicylate versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Clinical response Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

2 Histological response Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

Figuras y tablas -
Comparison 1. Bismuth subsalicylate versus placebo
Comparison 2. Budesonide versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Clinical response Show forest plot

2

57

Risk Ratio (M‐H, Fixed, 95% CI)

2.03 [1.25, 3.33]

2 Histological response Show forest plot

2

39

Risk Ratio (M‐H, Fixed, 95% CI)

2.44 [1.13, 5.28]

3 Adverse events Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

Figuras y tablas -
Comparison 2. Budesonide versus placebo
Comparison 3. Mesalazine versus mesalazine + cholestyramine

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Clinical response Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

2 Histological response Show forest plot

1

41

Risk Ratio (M‐H, Fixed, 95% CI)

0.99 [0.77, 1.28]

Figuras y tablas -
Comparison 3. Mesalazine versus mesalazine + cholestyramine
Comparison 4. Beclometasone dipropionate versus mesalazine

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Clinical response at 8 weeks Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

2 Maintenance of clinical response at 12 months Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

Figuras y tablas -
Comparison 4. Beclometasone dipropionate versus mesalazine